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Head of Quality

Cambridge, MA | Full Time
15 Days Ago

Job Description

Garuda Therapeutics is a privately-held, preclinical stage company developing off-the-shelf hematopoietic stem cell (HSC) therapies to treat a broad range of severe and life-threatening diseases. Garuda’s proprietary platform is poised to provide patients with rapid and broad access to durable, transgene-free, HLA-matched HSCs with the potential to cure a wide variety of diseases while eliminating the dependency on stem cell donors.

Position Overview:

Reporting to the CEO, the Head of Quality will be responsible for establishing a Quality department, including Quality Assurance and Quality Control functions, across all GXP areas, with an initial focus on GMP Quality. The Head of Quality will provide guidance to all functional areas within the Company to ensure compliance with global Quality standards for human drug products.

The Head of Quality will be responsible for:

  • Design, implement and maintain GXP QA and QC programs, and the compliance infrastructure, including the SOPs, training programs, and performing internal and external audits.
  • Lead and manage inspections by FDA, other regulatory agencies and commercial partners.
  • Lead Quality input on contracts and serve as the primary contact for the negotiation of quality agreements.
  • Work with the Company’s external suppliers including clinical research organizations (CROs), contract development and manufacturing organizations (CDMOs), and other vendors to ensure consistent quality and compliance.
  • Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs and GXP regulations.
  • Oversee compliance auditing program to fulfill regulatory requirements.
  • Develop, manage and monitor adherence to the overall Quality budget.
  • Develop, analyze and report business metrics and highlights.

Position Requirements:

  • Bachelor’s Degree in Science or a related field; advanced degree strongly preferred
  • 8 years’ experience in the pharmaceutical or biotechnology industry in a Quality or compliance role
  • 2 years experience as a functional head of a Quality department
  • Strong GxP knowledge in the pharmaceutical industry; experience in cell/gene therapy is preferred.
  • Hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure)
  • Proven record of developing and maintaining successful working relationships with regulatory agencies
  • Self-directed, accomplishment-driven individual with a sense of passion and urgency who in a cross-functional team environment
  • Proven team-leader and collaborative work experience in biotechnology or pharma: QC, Analytical Development, Drug process, Process development, or Engineering is necessary
  • Previous experience working with multiple CMO’s, establishing quality agreements, Vendor inspections and oversight of CMO’s product investigations as needed.
  • Knowledge of essential CMC activities and regulatory filing strategies

Skills for Head of Quality

The job skills required for Head of Quality include QA, Quality Assurance, GMP, QC, quality standards,and SOP etc. Having related job skills and expertise will give you an advantage when applying to be a Head of Quality. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Head of Quality. Select any job title you are interested in and start to search job requirements.

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